A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

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Ages Eligible for Study:

23 Years to 53 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.

Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251.

Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.

Exclusion Criteria:

Patients with eGFR of less than 15 mL/min/1.73 m2

Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant

Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan

Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study